The Food and Drug Administration announces that Shengyang Zhou of China has been sentenced to serve 87 months (over 7 years) in federal prison for trafficking and attempting to traffic in counterfeit goods, namely counterfeit versions of the pharmaceutical weight loss drug known as Alli. During the course of the investigation, law enforcement agents identified Zhou as the trafficker and importer into the U.S. of these counterfeit and unapproved purported weight loss related drugs. Zhou also identified himself as the manufacturer of the counterfeit Alli.

On June 6, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration’s interim final rule that will amend its regulations to lower the threshold for ordering administrative detention of food for human or animal consumption is effective July 3, 2011.

The Food and Drug Administration recently issued an interim final rule, effective July 3, 2011, to require persons submitting prior notice (PN) of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

On June 2-3, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration has issued a letter to foreign and domestic medical device and component establishments recommending certain immediate precautions to counter possible effects of the March 2011 Japan earthquake and Tsunami on medical devices and their components intended for market in the U.S.

The Food and Drug Administration has issued a letter announcing that Sandoz is coordinating with FDA to increase the availability of the norepinephrine bitartrate injection due to the current critical shortage. FDA states that at this time, no other company except Sandoz is authorized by FDA to import norepinephrine bitartrate injection for distribution. Any sales of imported Norepinephrine from any entity other than Sandoz will be considered in violation of the Federal Food, Drug and Cosmetic Act and may be subject to enforcement action by the FDA.

On June 1, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

On May 31, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration has announced that it issued 11 warning letters during the week of May 16-20 to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease. FDA cited the online retailers for a variety of illegal marketing claims that violate the Federal Food, Drug and Cosmetic Act, including use of terms such as: “Light”; “Low”; “Mild”; “Less toxic”; or “Safer.” In addition to these marketing violations, other cited violations included the illegal sale of flavored cigarettes.